Harbour BioMed is a Global Biotherapeutics Company primarily focused on inventing, developing, manufacturing and commercializing novel therapeutics for the treatment of serious medical conditions in oncology, and immunology. HBM has labs and business operations in Cambridge in the US, Rotterdam in Netherlands and Shanghai and Suzhou, China. We aim to help people with complex and debilitating conditions by identifying unmet medical and patient needs and driving strong science supported by our two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Our approach is shaped by our experienced team’s capability in delivering highly specialized treatments and forging close relationships with physicians and patients to understand the NextGen treatments that will provide hope to patients and their families around the world.
- Achieves study objectives by working with team members to set project priorities and milestones and resolve project conflicts.
- Assesses the operational feasibility of studies and recommends execution and risk mitigation plans.
- Co-monitors as needed.
- Develops and tracks study timelines, budget, and quality metrics.
- Ensures appropriate clinical resources are available for the clinical project.
- Ensures GCP and regulatory compliance is maintained.
- Leads the development of study-related documents, including study protocols, informed consent documents, study manuals and plans, trial master files, case report form design, etc.
- Maintains professional expertise through familiarity with therapeutic area and clinical research literature.
- Manages clinical projects from concept through clinical study report completion.
- Oversees clinical research study conduct.
- Manages, mentors, and develops direct reports.
- Organizes and leads the clinical project team. Leads regularly scheduled cross-functional study team meetings with internal and external resources.
- Participates in CRO and other vendor selection, negotiation and management, including monitoring of associated budgets and contracts.
- Participates in meetings with investigative sites, key opinion leaders and consultants as needed.
- Plays a part in the analysis, summary, and reporting of clinical data through the course of the study.
- Aides in the training and development of all clinical staff members.
- Performs other duties as assigned.
- Proactively identifies and resolves issues and participates in process improvement initiatives as required.
- Responds promptly and appropriately to study questions and issues raised by investigative sites, vendors, monitors, and consultants.
- Reviews and approves invoices from study vendors, investigators, consultants, etc.
- Evaluates monitoring reports with significant findings to confirm appropriate conclusions and actions taken.
- Reviews serious adverse events and other pertinent data with the medical monitor and drug safety personnel to identify safety trends and potential risks.
- Bachelor’s degree or above in a scientific discipline or equivalent with more than 10 years clinical research experience in an industry setting and a minimum of 2 years project-lead or management experience.
- Conscientious, influential person with an outstanding work ethic and strong personal discipline.
- Excellent organizational, leadership and problem-solving skills.
- Excellent written and verbal communication skills.
- Experience in leading cross-functional teams to meet goals and metrics.
- Success at managing global studies a plus.
- Know-how in managing Phase I, II, & III clinical studies.
- Experience in writing clinical study protocols, informed consent forms, and other clinical documents.
- Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies.
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
- Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities.
- Working knowledge of project development and update of clinical study timelines.
- Other tasks assigned by leaders.
If you are interested in applying for this position, please contact us at HBM.HR@harbourbiomed.com